Back to resultsMuscle Insulin Resistance in Aging (Mirage)
Primary Purpose
Insulin Resistance, Sarcopenia
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Energy Restriction-Induced Weight Loss
Sponsored by
About this trial
This is an interventional basic science trial for Insulin Resistance focused on measuring insulin resistance, muscle, health education, exercise
Eligibility Criteria
Inclusion Criteria:
- 65-80 years of age
- Stable weight (No Gain/Loss of >10 lbs in 6 months)
- Sedentary (≤ 1 continuous exercise/week)
- Non-smoker
- BMI ≥ 30 kg/m2
- Resting Blood Pressure ≤ 150 millimeters of mercury systolic and ≤ 95 millimeters of mercury diastolic
- Note from Primary care physician/Cardiologist for exercise clearance if positive stress test symptoms were observed from exercise test
- Must be willing to washout for 14 days from all diabetes medication and independent in self blood glucose monitoring during the washout periods (those with diabetes only)
Exclusion Criteria:
- Clinically significant cardiovascular disease including history of myocardial infarction, within the past year
- Peripheral Vascular Disease
- Hepatic, renal, muscular/neuromuscular, or active hematologic/oncologic disease
- Clinically diminished pulse
- Presence of bruits in lower extremities
- Previous history of pulmonary emboli
- Peripheral Neuropathy
Sites / Locations
- Translational Research Institute for Metabolism and Diabetes
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Exercise training protocol
Energy restriction-induced weight loss
Health Education
Arm Description
Outcomes
Primary Outcome Measures
Measure of intramyocellular lipids
A percutaneous muscle biopsy of the vastus lateralis will be obtained, and the intramyocellular lipids will be measured by high-performance liquid chromatography-tandem mass spectrometry.
Secondary Outcome Measures
Measure of insulin sensitivity
Insulin sensitivity will be measured using an intravenous catheter (glucose clamps) that will be placed in the antecubital vein for subsequent insulin and glucose infusions and for stable isotope infusions. This will measure insulin-stimulated changes in insulin signaling proteins and metabolism.
Full Information
NCT ID
NCT02230839
First Posted
August 7, 2014
Last Updated
July 21, 2023
Sponsor
AdventHealth Translational Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02230839
Brief Title
Muscle Insulin Resistance in Aging (Mirage)
Official Title
Muscle Insulin Resistance In Aging
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AdventHealth Translational Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to provide information regarding potential factors underlying metabolic dysfunction, insulin resistance, and loss of muscle mass in aging muscle.
Detailed Description
Study Objectives:
To determine the effects of diet-induced weight loss with and without the addition of exercise on mitochondrial biogenesis and energetic capacity, cellular redox state and insulin resistance.
To determine the effects of diet-induced weight loss with and without the addition of exercise on intramyocellular lipid profiles.
To determine the effects of diet-induced weight loss with and without exercise on skeletal muscle proteins mediating a program of autophagy and either loss or maintenance of muscle mass.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Sarcopenia
Keywords
insulin resistance, muscle, health education, exercise
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise training protocol
Arm Type
Experimental
Arm Title
Energy restriction-induced weight loss
Arm Type
Experimental
Arm Title
Health Education
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Participants will complete a progressive 6-month exercise training program, 4-5 days per week, 45 min per session (180 min per week), consisting mostly of walking (both outside and on an indoor treadmill) but with the option to include stationary cycling, elliptical and rowing machines, similar to what we have utilized previously to elicit significant improvements in insulin sensitivity in both middle-age and older adults (52-55). Beginning at week 8, these subjects will also perform 2 non-consecutive resistance exercise sessions per week, 30 min per session, focused on major muscle groups using resistance machines (total days of exercise will still be 4 to 5).
Intervention Type
Behavioral
Intervention Name(s)
Energy Restriction-Induced Weight Loss
Intervention Description
The goal of the weight loss intervention will be to produce a weight loss of 10% body weight. A reduction of 500-1000 kcal/day - based on baseline weight -and low fat (<30% of calories from fat) diet will be used as part of the weight loss intervention.
Primary Outcome Measure Information:
Title
Measure of intramyocellular lipids
Description
A percutaneous muscle biopsy of the vastus lateralis will be obtained, and the intramyocellular lipids will be measured by high-performance liquid chromatography-tandem mass spectrometry.
Time Frame
Visit 3 ~22 hours
Secondary Outcome Measure Information:
Title
Measure of insulin sensitivity
Description
Insulin sensitivity will be measured using an intravenous catheter (glucose clamps) that will be placed in the antecubital vein for subsequent insulin and glucose infusions and for stable isotope infusions. This will measure insulin-stimulated changes in insulin signaling proteins and metabolism.
Time Frame
Visit 3 ~22 hours
Other Pre-specified Outcome Measures:
Title
Measure muscle strength and power
Description
Muscle strength and power will be measured in participants who have successfully completed all screening procedures.
Measurement is obtained using a short physical performance battery, knee extension, and muscle power testing using a pneumatic-driven dynamometer.
Time Frame
Visit 2 (baseline) and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
65-80 years of age
Stable weight (No Gain/Loss of >10 lbs in 6 months)
Sedentary (≤ 1 continuous exercise/week)
Non-smoker
BMI ≥ 30 kg/m2
Resting Blood Pressure ≤ 150 millimeters of mercury systolic and ≤ 95 millimeters of mercury diastolic
Note from Primary care physician/Cardiologist for exercise clearance if positive stress test symptoms were observed from exercise test
Must be willing to washout for 14 days from all diabetes medication and independent in self blood glucose monitoring during the washout periods (those with diabetes only)
Exclusion Criteria:
Clinically significant cardiovascular disease including history of myocardial infarction, within the past year
Peripheral Vascular Disease
Hepatic, renal, muscular/neuromuscular, or active hematologic/oncologic disease
Clinically diminished pulse
Presence of bruits in lower extremities
Previous history of pulmonary emboli
Peripheral Neuropathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bret Goodpaster, PhD
Organizational Affiliation
Translational Research Institute for Metabolism and Diabetes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Translational Research Institute for Metabolism and Diabetes
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
12. IPD Sharing Statement
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Florida Hospital Translational Research Institute for Metabolism and Diabetes
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Muscle Insulin Resistance in Aging (Mirage)
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